WALTHAM, Mass. - Apellis Pharmaceuticals, Inc. (NASDAQ: NASDAQ:APLS), a biopharmaceutical company, received a negative opinion on its marketing authorization application for pegcetacoplan, an intravitreal treatment for geographic atrophy (GA), from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today.
Despite the setback, Apellis plans to request a re-examination of the application, with a final opinion anticipated in the fourth quarter of 2024.
The CHMP's decision comes after an Ad Hoc Expert Group meeting concluded that the size of the GA lesion is an acceptable primary outcome measure for trials in GA and that microperimetry is the best available functional measure for this condition. Geographic atrophy is an advanced form of age-related macular degeneration that leads to irreversible vision loss, affecting over one million Americans and five million people globally.
Pegcetacoplan, which is already approved in the United States for the treatment of GA secondary to age-related macular degeneration, is designed to regulate the complement cascade, a component of the immune system implicated in the onset and progression of various diseases.
Jeffrey Eisele, Ph.D., Chief Development Officer at Apellis, expressed determination to continue pursuing the drug's approval in Europe, noting the support for pegcetacoplan within the European retina community. Eisele emphasized the company's commitment to providing a treatment option for patients suffering from GA, a disease that significantly impairs independence and quality of life.
This news is based on a press release statement from Apellis Pharmaceuticals, Inc.
In other recent news, Apellis Pharmaceuticals has been the subject of significant developments. The company reported a successful first quarter in 2024, with SYFOVRE, its treatment for geographic atrophy, achieving net sales of $137.5 million, marking a 20% increase from the previous quarter. EMPAVELI, the treatment for paroxysmal nocturnal hemoglobinuria (PNH), generated $26 million in revenue.
In financial maneuvering, Apellis secured a non-dilutive, senior-secured credit facility that could provide up to $475 million through a partnership with Sixth Street. This strategic move is expected to reduce its non-operating cash requirements by approximately $222 million through the end of 2027, providing Apellis with increased flexibility and resources to invest in the launch of Syfovre and the development of its wider drug pipeline.
However, Wells Fargo (NYSE:WFC) adjusted its outlook on Apellis, reducing the price target to $48 from the previous $57 due to increased competition from Izervay. Despite the downward revision, Wells Fargo suggests that Apellis' stock price might stay within a certain range for the time being.
InvestingPro Insights
As Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) faces a challenging path ahead with the European Medicines Agency, the company's financial metrics and market performance provide a broader context for investors. According to InvestingPro data, Apellis has a market capitalization of $5.04 billion and has experienced a significant revenue growth of 394.93% in the last twelve months as of Q1 2024. Despite this impressive revenue surge, the company is not currently profitable, with a negative P/E ratio of -11.96, and an adjusted P/E ratio of -12.08 for the same period.
InvestingPro Tips highlight that analysts are optimistic about the company's sales growth in the current year, which could be a positive sign for future profitability. Additionally, Apellis has demonstrated a significant return over the last week, with a 9.06% price total return, reflecting a potentially favorable market sentiment. However, analysts do not anticipate that the company will be profitable this year, which may be a point of consideration for potential investors.
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While the immediate focus is on the company's regulatory challenges in Europe, the broader financial picture and market performance of Apellis Pharmaceuticals will continue to be key factors for investors monitoring the company's progress.
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